I 

118TH CONGRESS 

2D SESSION H. R. 9105 

To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety 

of food and limit the presence of contaminants in infant and toddler 

food, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 23, 2024 

Mr. KRISHNAMOORTHI (for himself and Mr. CA ́RDENAS) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

ensure the safety of food and limit the presence of contaminants in infant and toddler food, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Baby Food Safety Act 

5 of 2024’’. 


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1 SEC. 2. DEFINITION OF INFANT OR TODDLER FOOD. 

2 Section 201 of the Federal Food, Drug, and Cosmetic 

3 Act (21 U.S.C. 321) is amended by adding at the end the 

4 following: 

5 ‘‘(tt) The term ‘infant or toddler food’ means food 

6 that purports to be, or is represented as being, for infants 

7 or children up to the age of 24 months. Such term does 

8 not include infant formula.’’. 

9 SEC. 3. CONTAMINANTS IN FOOD, INCLUDING INFANT OR 

10 TODDLER FOOD. 

11 (a) IN GENERAL.—Chapter IV of the Federal Food, 

12 Drug, and Cosmetic Act (21 U.S.C. 341 et seq.) is amend13 ed by adding at the end the following: 

14 ‘‘SEC. 425. CONTAMINANTS IN FOOD, INCLUDING INFANT 

15 OR TODDLER FOOD. 

16 ‘‘(a) ADMINISTRATIVE ORDERS FOR CONTAMINANTS, 

17 INCLUDING TOXIC ELEMENTS, IN FOOD.— 

18 ‘‘(1) IN GENERAL.— 

19 ‘‘(A) REQUIRED LIMITS.—The Secretary, 

20 by administrative order, shall establish limits on 

21 the toxic elements of lead, cadmium, mercury, 

22 and arsenic (or a species of any such toxic ele23 ment) in— 

24 ‘‘(i) any infant or toddler food; and 

25 ‘‘(ii) food predominantly composed of 

26 a fruit or vegetable puree or juice; 


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1 ‘‘(B) ADDITIONAL LIMITS.—If the Sec2 retary determines appropriate upon review of 

3 relevant health data and other relevant avail4 able information, the Secretary, by administra5 tive order, may— 

6 ‘‘(i) establish limits for contaminants, 

7 including toxic elements, in infant or tod8 dler food, in addition to the limits for toxic 

9 elements described in subparagraph (A); 

10 and 

11 ‘‘(ii) establish limits for contaminants, 

12 including toxic elements, in food predomi13 nantly composed of a fruit or vegetable 

14 puree or juice, in addition to the limits for 

15 toxic elements described in subparagraph 

16 (A). 

17 ‘‘(2) PROCEDURE.—In establishing or revising 

18 any limit under paragraph (1), the Secretary shall— 

19 ‘‘(A) evaluate relevant health data and as20 sessments, data from State and local health de21 partments, and other information the Secretary 

22 considers relevant; 

23 ‘‘(B) take into account relevant differences 

24 among food types, groups, and categories, as 

25 appropriate, including the extent to which the 


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1 use of such substances cannot be avoided in the 

2 production of the applicable food and its ingre3 dients, based on an evaluation of alternative in4 gredients, use of best manufacturing and agri5 cultural practices, and full compliance with sec6 tion 418; and 

7 ‘‘(C) notwithstanding the requirements of 

8 subchapter II of chapter 5 of title 5, United 

9 States Code, and chapter 6 of title 5, United 

10 States Code— 

11 ‘‘(i) publish any administrative order 

12 under paragraph (1) in the Federal Reg13 ister following— 

14 ‘‘(I) publication of a proposed 

15 order in the Federal Register; and 

16 ‘‘(II) consideration of comments 

17 to a public docket open for not fewer 

18 than 45 calendar days; and 

19 ‘‘(ii) set forth in any proposed or final 

20 administrative order under paragraph (1) 

21 a substantive summary of the valid sci22 entific evidence concerning the proposed or 

23 final limit. 

24 ‘‘(3) CHANGES TO LIMITS.—If the Secretary de25 termines appropriate after review of relevant data 


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1 and assessments and other available and relevant 

2 health information, the Secretary may revise any 

3 limit established under this subsection by adminis4 trative order published in the Federal Register in ac5 cordance with paragraph (2). 

6 ‘‘(4) TIMEFRAME FOR INITIAL LIMITS.— 

7 ‘‘(A) PROPOSED ORDERS.—Subject to the 

8 requirements of paragraph (2), the Secretary 

9 shall issue proposed orders for limits under 

10 paragraph (1)(A) as follows: 

11 ‘‘(i) For lead, not later than Decem12 ber 31, 2025. 

13 ‘‘(ii) For arsenic, not later than De14 cember 31, 2025. 

15 ‘‘(iii) For cadmium, not later than 

16 April 30, 2026. 

17 ‘‘(iv) For mercury, not later than 

18 April 30, 2028. 

19 ‘‘(B) FINAL ORDERS.—The Secretary shall 

20 issue each final administrative order for a limit 

21 established pursuant to subparagraph (A) or 

22 (B) of paragraph (1) not later than 18 months 

23 after issuance of the respective proposed order. 

24 ‘‘(5) CRITERIA.—The limits established under 

25 this section shall represent the level at which the 


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1 contaminant may render the infant or toddler food 

2 injurious to health. In determining such limits the 

3 Secretary shall take into account the extent to which 

4 the use of such substance cannot be avoided in the 

5 production of each such food and its ingredients, 

6 based on an evaluation of alternative ingredients, 

7 use of best manufacturing and agricultural practices, 

8 and compliance with section 418. 

9 ‘‘(6) ADULTERATED FOOD.—A food may be de10 termined adulterated, at the final product form, 

11 under section 402(j), if such food bears or contains 

12 any contaminant (including any toxic element) in ex13 cess of a limit established under this subsection. 

14 ‘‘(7) PERIODIC REVIEW.—The Secretary shall 

15 review, not less frequently than every 4 years, the 

16 limits established under this subsection, taking into 

17 consideration relevant information and available 

18 data to consider whether such limits should be re19 vised, following the procedure described in para20 graph (2), in accordance with the criteria specified 

21 in paragraph (5). 

22 ‘‘(b) SAMPLING AND TESTING FOR TOXIC ELEMENTS

23 AND CONTAMINANTS IN FOOD, INCLUDING INFANT AND

24 TODDLER FOOD.— 


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1 ‘‘(1) IN GENERAL.—Beginning not later than 

2 180 days after the date of enactment of the Baby 

3 Food Safety Act of 2024, the owner, operator, or 

4 agent in charge of a facility engaged in manufac5 turing or processing infant or toddler food; food pre6 dominantly composed of a fruit or vegetable puree or 

7 juice; or such other food as the Secretary may speci8 fy by regulation, for consumption in the United 

9 States, shall— 

10 ‘‘(A) have a control program in place for 

11 toxic elements and contaminants subject to lim12 its under subsection (a)(1); 

13 ‘‘(B) collect representative samples of each 

14 such food in final product form in accordance 

15 with a sampling plan described in paragraph 

16 (2); and 

17 ‘‘(C) conduct testing of the samples col18 lected from the final food product for toxic ele19 ments and contaminants, in accordance with a 

20 sampling plan described in paragraph (2). 

21 ‘‘(2) REQUIREMENTS FOR SAMPLING AND TEST22 ING PLAN.— 

23 ‘‘(A) IN GENERAL.—The owner, operator, 

24 or agent in charge of a facility described in 

25 paragraph (1) shall— 


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1 ‘‘(i) prepare a written plan for all 

2 sampling and testing required under this 

3 subsection; and 

4 ‘‘(ii) ensure that all sampling and 

5 testing conducted under this subsection is 

6 conducted in accordance with the plan de7 scribed in clause (i). 

8 ‘‘(B) SAMPLING PLAN.—A sampling and 

9 testing plan required by subparagraph (A) shall 

10 identify— 

11 ‘‘(i) the number of sampling units and 

12 sample unit size based upon appropriate 

13 criteria for identifying, in a representative 

14 fashion, the levels of toxic elements and 

15 contaminants in each food; 

16 ‘‘(ii) one or more appropriate test 

17 methods and procedures to be used to ana18 lyze the samples; and 

19 ‘‘(iii) appropriate testing frequencies 

20 not less frequently than every quarter and 

21 whenever a significant change in the prod22 uct or process necessitates such testing. 

23 ‘‘(C) GUIDANCE.—Not later than 18 

24 months after the date of enactment of the Baby 

25 Food Safety Act of 2024, the Secretary shall 


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1 issue guidance to assist facilities described 

2 under paragraph (1) with developing sampling 

3 and testing plans. Such guidance shall address 

4 the standards for adequate and appropriate 

5 sampling and testing of each toxic element and 

6 contaminant as required by the Secretary, the 

7 minimum frequency at which samples should be 

8 tested for toxic elements and contaminants or 

9 specific species of toxic elements or contami10 nants, and standards for compliance. 

11 ‘‘(3) CONTAMINANTS TO BE TESTED.—In car12 rying out the sampling and testing under this sub13 section, the owner, operator, or agent in charge of 

14 a facility described in paragraph (1) shall ensure 

15 that each sample is tested for levels of— 

16 ‘‘(A) lead, cadmium, mercury, and arsenic; 

17 and 

18 ‘‘(B) any other contaminant that the Sec19 retary may specify, in accordance with the sam20 pling plan under paragraph (2). 

21 ‘‘(4) FOODS TO BE TESTED.—The sampling 

22 and testing conducted under this subsection shall be 

23 conducted for— 

24 ‘‘(A) infant and toddler foods, in final 

25 product form; 


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1 ‘‘(B) foods predominantly composed of a 

2 fruit or vegetable puree or juice; and 

3 ‘‘(C) such other foods in final product 

4 form as the Secretary has specified, as appro5 priate for the protection of public health. 

6 ‘‘(5) RECORDKEEPING.— 

7 ‘‘(A) IN GENERAL.—The owner, operator, 

8 or agent in charge of a facility described in 

9 paragraph (1) shall maintain, for not less than 

10 2 years or the shelf life of each food product 

11 manufactured or processed by the facility, 

12 whichever is longer, records documenting the 

13 sampling plan and results of testing conducted 

14 under this subsection with respect to the food. 

15 The owner, operator, or agent in charge of such 

16 a facility shall make such records available for 

17 inspection and copying by the Secretary upon 

18 request by the Secretary. 

19 ‘‘(B) REQUIREMENTS.—The records main20 tained as required under subparagraph (A) 

21 shall include— 

22 ‘‘(i) a detailed description of the foods 

23 sampled and tested; 

24 ‘‘(ii) the number of samples and tests 

25 performed; 


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1 ‘‘(iii) the size and number of items in 

2 each sample unit; 

3 ‘‘(iv) a copy of the sampling plan re4 quired under paragraph (2); 

5 ‘‘(v) identification of the entity con6 ducting the sampling; 

7 ‘‘(vi) identification of the entity con8 ducting the testing; 

9 ‘‘(vii) identification of the analytical 

10 methods used to perform the sampling and 

11 testing; 

12 ‘‘(viii) analytical findings of the sam13 pling and testing; and 

14 ‘‘(ix) such other data and information 

15 as the Secretary may require. 

16 ‘‘(C) APPLICABILITY.—The requirements 

17 of this paragraph shall apply to all records of 

18 sampling and testing conducted pursuant to 

19 this subsection, regardless of the findings. 

20 ‘‘(6) LABORATORY ACCREDITATION.—The 

21 owner, operator, or agent in charge of a facility de22 scribed in paragraph (1) shall ensure that testing re23 quired pursuant to this subsection is performed in 

24 accordance with international standards by a labora25 tory that— 


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1 ‘‘(A) is in compliance with the require2 ments regarding laboratory accreditation de3 scribed in section 422; or 

4 ‘‘(B) if the requirements described in sub5 paragraph (A) do not apply to the laboratory, 

6 is accredited by an accreditation body that con7 forms to international accreditation standards. 

8 ‘‘(7) SAMPLING AND TESTING PROGRAM.—The 

9 Secretary shall develop and implement a sampling 

10 and testing program for infant and toddler food that 

11 is sufficient to— 

12 ‘‘(A) support the periodic review under 

13 subsection (a)(7) of limits on toxic elements in 

14 infant and toddler food; and 

15 ‘‘(B) independently verify that products 

16 are compliant with the limits proscribed pursu17 ant to this subsection. 

18 ‘‘(c) RECORD AVAILABILITY.— 

19 ‘‘(1) IN GENERAL.—Upon request by the Sec20 retary, the owner, operator, or agent in charge of a 

21 facility described in subsection (b)(1) shall— 

22 ‘‘(A) make all records required under this 

23 section available promptly to the Secretary for 

24 inspection and copying; and 


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1 ‘‘(B) provide within a reasonable time an 

2 English translation of such records maintained 

3 in a language other than English. 

4 ‘‘(2) RECORD AVAILABILITY.—Any records that 

5 the Secretary may inspect under this section shall, 

6 upon the request of the Secretary, be provided to the 

7 Secretary by the owner, operator, or agent in charge 

8 of a facility described in subsection (b)(1), in ad9 vance of or in lieu of an inspection, within a reason10 able timeframe, within reasonable limits, and in a 

11 reasonable manner, and in either electronic or phys12 ical form, at the expense of such owner, operator, or 

13 agent. The Secretary’s request shall include a suffi14 cient description of the records requested. 

15 ‘‘(3) CONFIRMATION.—Upon receipt of records 

16 requested under paragraph (1) or (2), the Secretary 

17 shall provide to the owner, operator, or agent de18 scribed in paragraph (2) confirmation of the receipt. 

19 ‘‘(4) AUTHORITY OF THE SECRETARY.—Noth20 ing in this subsection supplants the authority of the 

21 Secretary to conduct sampling, testing, or inspec22 tions otherwise permitted under this Act in order to 

23 ensure compliance with this Act. 

24 ‘‘(d) DELAYED APPLICABILITY.—The requirements 

25 for sampling and testing under this section shall apply beVerDate Sep 11 2014 20:30 Aug 27, 2024 Jkt 049200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\H9105.IH H9105

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1 ginning on the date that is 2 years after the date of enact2 ment of this subsection.’’. 

3 (b) IMPORTER REQUIREMENTS.—Section 805(c)(4) 

4 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

5 384a(c)(4)) is amended, by inserting ‘‘monitoring and 

6 verifying the accuracy of records described in section 

7 425(b)’’ after ‘‘for shipments,’’. 

8 (c) ENFORCEMENT.— 

9 (1) ADULTERATION.—Section 402 of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 342) 

11 is amended by adding at the end the following: 

12 ‘‘(j) If it is an article of food in final product form 

13 that is an infant and toddler food, a food predominantly 

14 composed of a fruit or vegetable puree or juice, or such 

15 other food as the Secretary may specify and— 

16 ‘‘(1) such food bears or contains any toxic ele17 ment or contaminant in excess of a limit established 

18 under section 425(a); or 

19 ‘‘(2) the owner, operator, or agent in charge of 

20 a facility that manufactures or processes the food is 

21 not in compliance with subsection (b) or (c) of sec22 tion 425.’’. 

23 (2) PROHIBITED ACT.—Section 301 of the Fed24 eral Food, Drug, and Cosmetic Act (21 U.S.C. 331) 

25 is amended by adding at the end the following: 


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1 ‘‘(jjj) The failure of an owner, operator, or agent in 

2 charge of a facility that manufactures or processes food 

3 to comply with applicable requirements under subsection 

4 (b) or (c) of section 425.’’. 

5 SEC. 4. IMPLEMENTATION OF FOOD TRACEABILITY PLAN; 

6 STUDY ON INSPECTIONS; REPORTING ON IN7 SPECTIONS. 

8 (a) IMPLEMENTATION PLAN.—The Secretary of 

9 Health and Human Services (referred to in this section 

10 as the ‘‘Secretary’’), acting through the Commissioner of 

11 Food and Drugs, in coordination with the FDA Human 

12 Foods Program and the Center for Food Safety and Ap13 plied Nutrition, shall finalize an implementation plan for 

14 the Food and Drug Administration to achieve its goal of 

15 compliance, not later than January 20, 2026, with the rule 

16 issued by the Food and Drug Administration titled, ‘‘Re17 quirements for Additional Traceability Records for Cer18 tain Foods’’ (87 Fed. Reg. 70910 (November 21, 2022)) 

19 (or any successor rule). Such plan shall include a descrip20 tion of— 

21 (1) any resource needs of the Food and Drug 

22 Administration; 

23 (2) strategies for facilitating compliance with 

24 the rule; and 


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1 (3) detailed plans for communicating with and 

2 educating regulated entities, non-Federal regulatory 

3 partners, and regulatory staff of the Food and Drug 

4 Administration about the requirements under the 

5 rule. 

6 (b) STUDY ON INSPECTIONS.—The Secretary shall— 

7 (1) conduct a study to— 

8 (A) determine the annual number of facil9 ity inspections that is sufficient to determine 

10 that imported foods are held to the same safety 

11 standards as domestic food; and 

12 (B) identify whether such inspection tar13 gets are consistent with the targets in the most 

14 recent annual report regarding food conducted 

15 under section 1003(h) of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 393(h)); 

17 and 

18 (2) not later than 1 year after the date of en19 actment of this Act, submit a report to Congress on 

20 the findings of such study, and, if applicable, any 

21 factors preventing the Secretary from meeting its 

22 goal for the number of inspections and a plan to en23 sure that such goal is met in the next 2 years. 


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1 (c) ANNUAL REPORT REGARDING FOOD.—Section 

2 1003(h)(1) of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 393(h)(1)) is amended— 

4 (1) in subparagraph (E), by striking ‘‘and’’ at 

5 the end; 

6 (2) in subparagraph (F), by striking the period 

7 and inserting ‘‘; and’’; and 

8 (3) by adding at the end the following: 

9 ‘‘(G) the nature of domestic facility and 

10 foreign facility inspections described in subpara11 graph (C), the aggregate inspection findings of 

12 such inspections, and the compliance rate of 

13 foreign food importers with certification stand14 ards;’’. 

15 SEC. 5. RECORDS FOR OR IN LIEU OF CERTAIN INSPEC16 TIONS. 

17 Section 704(a)(4) of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 374(a)(4)) is amended— 

19 (1) by redesignating subparagraphs (B) 

20 through (D) as subparagraphs (C) through (E), re21 spectively; 

22 (2) by inserting after subparagraph (A) the fol23 lowing new subparagraph: 

24 ‘‘(B)(i) Any records or other information that the 

25 Secretary may remotely inspect or copy under authority 


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1 of this Act from a person that owns or operates, or is an 

2 agent in charge of, an establishment that is engaged in 

3 any of the activities described in clause (ii) shall, upon 

4 the request of the Secretary, be provided to the Secretary 

5 by such person, in advance of, at the time of, or in the 

6 case in which an in-person inspection would be unsafe, in 

7 lieu of, an in-person, on-site inspection, within a reason8 able timeframe, within reasonable limits, and in a reason9 able manner, and in either electronic or physical form, at 

10 the expense of such person. The Secretary’s request shall 

11 include a sufficient description of the records or other in12 formation requested. 

13 ‘‘(ii) The activities described in this clause are 

14 records relating to— 

15 ‘‘(I) the manufacturing, processing, sampling, 

16 testing, packing, transporting, distributing, receiv17 ing, holding, or importing of an article of food; or 

18 ‘‘(II) the distribution or use of animal feed 

19 bearing or containing a veterinary feed directive 

20 drug, or the issuance of a veterinary feed directive.’’; 

21 and 

22 (3) by adding at the end the following: 

23 ‘‘(F) Section 703 does not apply to records obtained 

24 or copied, or other information obtained or copied pursu25 ant to a request made under this section.’’. 


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1 SEC. 6. MANDATORY RECALL AUTHORITY. 

2 Section 423(a) of the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 350l(a)) is amended by inserting 

4 after ‘‘animals,’’ the following: ‘‘or that an article of food 

5 is adulterated under paragraph (a)(1) or (j) of section 

6 402,’’. 

7 SEC. 7. ENVIRONMENTAL MONITORING. 

8 Chapter IV of the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 341 et seq.), as amended by section 3, 

10 is further amended by adding the following: 

11 ‘‘SEC. 426. ENVIRONMENTAL MONITORING OF INFANT AND 

12 TODDLER FOOD. 

13 ‘‘(a) IN GENERAL.—A manufacturer of infant and 

14 toddler food (other than infant formula) shall establish 

15 and implement an environmental monitoring program to 

16 verify the effectiveness of sanitation and hygiene controls 

17 during the manufacturing and packaging process where 

18 the food has the potential to be exposed to pathogens. The 

19 environmental monitoring program shall be written and 

20 include procedures for determining sample location, num21 ber of samples to be taken, and timing and frequency of 

22 sample collection and testing. 

23 ‘‘(b) ORGANISMS SAMPLED.—The environmental 

24 monitoring program under subsection (a) shall include 

25 testing for environmental pathogens or a reliable indicator 

26 organism. 


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1 ‘‘(c) SAMPLING LOCATION AND NUMBER OF SAM2 PLES.—A manufacturer of infant and toddler food shall 

3 ensure that the sampling locations from which samples 

4 will be taken, and the number of sites to be tested during 

5 routine environmental monitoring are adequate to deter6 mine whether sanitation and hygiene controls are effective. 

7 ‘‘(d) TIMING AND FREQUENCY.—The timing and fre8 quency for collecting and testing samples shall be ade9 quate to determine whether sanitation and hygiene con10 trols are effective, and shall occur not less frequently than 

11 every 3 years. 

12 ‘‘(e) RECORDS.— 

13 ‘‘(1) AVAILABILITY TO THE SECRETARY.—A 

14 manufacturer of infant and toddler food shall make 

15 all the records required under this section available 

16 promptly to the Secretary, upon request by the Sec17 retary, for inspection and copying. 

18 ‘‘(2) MAINTENANCE OF RECORDS PERTAINING

19 TO ENVIRONMENTAL MONITORING.—Records of envi20 ronmental sampling, testing, and monitoring con21 ducted pursuant to this section shall be established 

22 and maintained by the manufacturer for not less 

23 than 2 years or the shelf-life of the food, whichever 

24 is longer. 


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1 ‘‘(3) CONDITIONS OF INSPECTION.—Any 

2 records or other information that the Secretary may 

3 inspect under this section shall, upon the request of 

4 the Secretary, be provided to the Secretary by the 

5 manufacturer, in advance of, at the time of, or in 

6 the case in which an in-person inspection would be 

7 unsafe, in lieu of, an in-person, on-site inspection, 

8 within a reasonable timeframe, within reasonable 

9 limits, and in a reasonable manner, and in either 

10 electronic or physical form, at the expense of such 

11 manufacturer. The Secretary’s request shall include 

12 a sufficient description of the records requested. 

13 ‘‘(4) CONFIRMATION OF RECEIPT.—Upon re14 ceipt of the records requested under paragraph (3), 

15 the Secretary shall provide to the manufacturer con16 firmation of receipt. 

17 ‘‘(f) AUTHORITY OF THE SECRETARY.—Nothing in 

18 this section supplants the authority of the Secretary to 

19 conduct inspections otherwise permitted under this Act in 

20 order to ensure compliance with this Act. 

21 ‘‘(g) EFFECTIVE DATE.—The requirements of this 

22 section shall apply beginning on the date that is 2 years 

23 after the date of enactment of the Baby Food Safety Act 

24 of 2024. 


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1 ‘‘(h) RULE OF CONSTRUCTION.—Nothing in this sec2 tion shall be construed to exempt any manufacturer from 

3 the requirements of this Act, including the requirements 

4 under section 418.’’. 

Æ 


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